DEN230055 is an FDA 510(k) submission for the FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System. This device is classified as a Applicator, Negative Pressure, External, Ocular (Class II - Special Controls, product code QQJ).
Submitted by Balance Ophthalmics, Inc. (Sioux Falls, US). The FDA issued a Not Cleared (DENG) decision on June 27, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5000. External Ocular Negative Pressure System. An External Ocular Negative Pressure System Uses Hardware And Software To Create Negative Pressure In Front Of The Eye To Temporarily Lower Intraocular Pressure In Glaucoma Patients..
| 510(k) Number | DEN230055 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 25, 2023 |
| Decision Date | June 27, 2024 |
| Days to Decision | 307 days |
| Submission Type | Direct |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | QQJ - Applicator, Negative Pressure, External, Ocular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5000 |
| Definition | External Ocular Negative Pressure System. An External Ocular Negative Pressure System Uses Hardware And Software To Create Negative Pressure In Front Of The Eye To Temporarily Lower Intraocular Pressure In Glaucoma Patients. |